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pharmacovigilance – fundamentals and inspections

pharmacovigilance – fundamentals and inspections

Pharmacovigilance is an activity that must be performed by all marketing authorisation holders (MAHs) throughout the lifecycle of the medicinal product or for products for which they hold an authorisation.

The course will be delivered over a period of two days. Day 1, will include the basic requirements for pharmacovigilance for MAHs and applicants as laid down by European and National law with an additional focus on the implications of pharmacovigilance inspections, now a routine part of European medicinal product regulation.

The non-technical aspects of inspection (also known as the “soft skills”) are common to most forms of inspections and will also be covered on Day 1 of this two-day intensive course.

On Day 2 the focus will be on Risk Management and reporting of adverse reactions, including expedited and periodic reporting.

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